MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS FULL ELECTRIC FOOT SPRING 9153638201; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5410IVC

Device Problems Material Discolored (1170); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A return was issued and the product has been returned and is awaiting evaluation. a follow up will be filed if/when any additional information is provided.

Event Description

The power cord sparked and is blackened.

Manufacturer Narrative

Additional/updated information was provided by the dealer: dealer stated that he arrived the day after the incident to remove the power cord from the bed.At that time, no additional components were plugged into the outlet and no damage was identified with the outlet.It is unknown whether the end user had anything else plugged into the outlet at the time of the incident.The replacement cable was received and installed on the bed, and the bed now functions correctly with no further issues alleged.The power cable was returned for evaluation, and subsequent testing verified the complaint.Per the expanded evaluation report, the neutral terminal of the j2 outlet connector was blackened and showed signs of damage.The damage appeared to have been caused by exposure to sparking within a damaged outlet.The j1 connector to the control box did not show any sign of damage.

Event Description

The power cord sparked and is blackened.

• Brand Name: FULL ELECTRIC FOOT SPRING 9153638201
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5970317
• MDR Text Key: 55686307
• Report Number: 1031452-2016-03588
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5410IVC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1